← Product Code [NAE](/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE) · K810902

# IP-758 BURN WOUND DRESSING (K810902)

_Exopack · NAE · Sep 11, 1981 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K810902

## Device Facts

- **Applicant:** Exopack
- **Product Code:** [NAE](/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE.md)
- **Decision Date:** Sep 11, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4022
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K810902](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NAE/K810902)

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